carbidopa and levodopa (51079-923)

Drug Facts

Product Profile

Brand Name carbidopa and levodopa

Generic Name carbidopa and levodopa

Labeler mylan institutional inc.

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

carbidopa 50 mg/1, levodopa 200 mg/1

Manufacturer

Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-923

Product ID 51079-923_3a39bb13-44d1-2652-e063-6294a90ad211

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA075091

Listing Expiration 2026-12-31

Marketing Start 1999-12-01

Pharmacologic Class

Established (EPC)

aromatic amino acid [epc] aromatic amino acid decarboxylation inhibitor [epc]

Mechanism of Action

dopa decarboxylase inhibitors [moa]

Chemical Structure

amino acids, aromatic [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51079923

Hyphenated Format 51079-923

Supplemental Identifiers

RxCUI

308988 308989

UNII

46627O600J MNX7R8C5VO

NUI

N0000193220 M0370111 N0000175754 N0000175755

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name carbidopa and levodopa (source: ndc)

Generic Name carbidopa and levodopa (source: ndc)

Application Number ANDA075091 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

50 mg/1
200 mg/1

source: ndc

Packaging

100 BLISTER PACK in 1 CARTON (51079-923-20) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-923-01)

source: ndc

Packages (1)

51079-923-20 100 BLISTER PACK in 1 CARTON (51079-923-20) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-923-01)

Ingredients (2)

carbidopa (50 mg/1) levodopa (200 mg/1)

Linked Drug Pages (1)

Carbidopa and Levodopa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3a39bb13-44d1-2652-e063-6294a90ad211", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175754", "N0000175755"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["308988", "308989"], "spl_set_id": ["16f9e4d1-6953-4d4f-b4cf-ad95a856ac25"], "pharm_class_cs": ["Amino Acids, Aromatic [CS]"], "pharm_class_epc": ["Aromatic Amino Acid [EPC]", "Aromatic Amino Acid Decarboxylation Inhibitor [EPC]"], "pharm_class_moa": ["DOPA Decarboxylase Inhibitors [MoA]"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (51079-923-20)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-923-01)", "package_ndc": "51079-923-20", "marketing_start_date": "19991201"}], "brand_name": "Carbidopa and Levodopa", "product_id": "51079-923_3a39bb13-44d1-2652-e063-6294a90ad211", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "51079-923", "generic_name": "carbidopa and levodopa", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbidopa and Levodopa", "active_ingredients": [{"name": "CARBIDOPA", "strength": "50 mg/1"}, {"name": "LEVODOPA", "strength": "200 mg/1"}], "application_number": "ANDA075091", "marketing_category": "ANDA", "marketing_start_date": "19991201", "listing_expiration_date": "20261231"}